Investigation of the bioavailability of linagliptin after concomitant multiple oral administration of 5 mg linagliptin tablets and 600 mg rifampicin (Treatment A) in comparison to multiple oral administration of 5 mg linagliptin tablets given alone (Treatment B)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Area under the steady state concentration-time curve of linagliptin in plasma (AUCτ,ss)
Time frame: up to 19 days
Maximum measured steady state concentration of linagliptin in plasma (Cmax,ss)
Time frame: up to 19 days
Dipeptidyl-peptidase 4 (DPP-4) inhibition
Time frame: up to 19 days
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1790
Time frame: up to 19 days
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1790
Time frame: up to 19 days
Ratio of urinary concentrations of 6β-hydroxycortisol to cortisol
Time frame: screening, days 1 and 6 of treatment A, days 4, 6, 8 and 12 of treatment B always in the morning before drug administration
Aet1-t2,ss ( amount of analyte that is eliminated in urine from the time point t1 to time point t2 under steady state conditions) of linagliptin
Time frame: up to 19 days
fet1-t2,ss ( fraction of administered drug excreted unchanged in urine at steady state over the respective time interval, where t1 and t2 define beginning and end times of the time interval) of linagliptin
Time frame: up to 19 days
Number of patients with adverse events
Time frame: up to 42 days
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Assessment of global tolerability by investigator on a 4-point scale
Time frame: up to 21 days after last drug administration
Number of patients with abnormal findings in physical examination
Time frame: up to 21 days after last drug administration
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 21 days after last drug administration
Number of patients with clinically significant changes in Vital signs (Blood Pressure (BP), Pulse Rate (PR))
Time frame: up to 21 days after last drug administration
Number of patients with clinically significant changes in 12-lead ECG (electrocardiogram)
Time frame: up to 21 days after last drug administration